Varenicline on Reward Responses and Cognition in Adolescent Smokers (GRAND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01624428
First received: June 18, 2012
Last updated: January 30, 2014
Last verified: January 2014

June 18, 2012
January 30, 2014
June 2012
November 2013   (final data collection date for primary outcome measure)
  • neural responses to the MIDT [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Monetary Incentive Delay Task (MIDT) will be administered during the fMRI at the end of 14 days of varenicline treatment
  • neural responses to the ROC [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Regulation of Craving (ROC)will be administered during the fMRI at the end of 14 days of varenicline treatment
  • neural responses to the Stroop [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment
Same as current
Complete list of historical versions of study NCT01624428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Varenicline on Reward Responses and Cognition in Adolescent Smokers
Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers

This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have differential brain responses to anticipation of rewards, during exposure to the Stroop task, and in response to tobacco cues.

This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have increased activation of the ventral striatum (VS) in response to anticipation of rewards in the Monetary Incentive Delay Task (MIDT), decreased activation of the dorsolateral prefrontal cortex (dlPFC) during exposure to incongruent stimuli in the Stroop task, and reduced activation of the ventral striatum in response to tobacco cues, and increased activation of the dlPFC during regulation of responses to tobacco cues during the Regulation of Craving (ROC) task. The results of this pilot project will have important implications regarding the use of varenicline for treating tobacco dependence and understanding varenicline's neurobiological effects in adolescent smokers.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Tobacco Use Disorders
  • Drug: Varenicline
    1 mg bid varenicline titrated over a 2 week period
    Other Name: Chantix
  • Drug: Placebo
    1 mg bid placebo titrated over a 2 week period
  • Active Comparator: varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between 16-19 years of age
  • Able to read and write English
  • Smoking 5 or more cigarettes on a daily basis, for at least one year
  • Not seeking smoking cessation treatment
  • Weighing > 55 kg (121 lbs)

Exclusion Criteria:

  • Current criteria for abuse or dependence on another psychoactive substance.
  • Current diagnosis of any clinical significant psychiatric disease like major depressive disorder, panic or anxiety disorder, psychosis, schizophrenia, bipolar disorder.
  • Those with a prior suicide attempt or with active suicidal ideation at baseline
  • Any regular use of any psychoactive drugs including anxiolytics and antidepressants
  • Pregnant or lactating girls: females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to study medication administration until 30 days after the last dose of study medication. Acceptable methods of contraception are: abstinence; any form of hormonal contraception such as Depo-Provera, daily oral contraceptive, transdermal patch, or Nuva-ring; intra-uterine device, sterilization; or double barrier contraception which is a combination of any two of the following methods: condoms, spermicide, diaphragm.
  • Evidence or history of clinically significant neurological, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or allergic disease.
  • History of prior use of or sensitivity to varenicline.
  • Color-blindness
  • History of significant head trauma
  • Metal in body
  • Other medical conditions contra-indicated for MRI
  • Past history of marked irritability or agitation when attempting to quit smoking, determined by the Minnesota Nicotine Withdrawal Questionnaire.
Both
16 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01624428
1108008929
Yes
Yale University
Yale University
Not Provided
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
Yale University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP